Publication Date: 2005-12-05
Edited by Peter Bonate and Danny Howard
Volume 1 discusses the role pharmacokinetics plays in selected clinical study designs. Included are first-time-in-man studies, biopharmaceutical, and special population studies. The chapters are written to provide the reader with a familiarity for scientific and operational considerations, and to provide insight into the authors' practical experiences conducting these studies. Volume 1 also discusses the application of pharmacokinetic analysis techniques to drug development - from noncompartmental analysis and interspecies scaling to deconvolution and clinical trial simulation. Volume 1 closes with a discussion on the analysis of clinical safety data in pharmacokinetic studies. See also the table of contents.
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